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Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons ...

FDA Recall #D-0844-2020 — Class III — December 13, 2019

Recall #D-0844-2020 Date: December 13, 2019 Classification: Class III Status: Terminated

Product Description

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61

Reason for Recall

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Recalling Firm

The Harvard Drug Group — Livonia, MI

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

246 Cartons

Distribution

U.S.A. Nationwide

Code Information

Lot# M02465D

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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